Anika Therapeutics Inc. won FDA approval for Orthovisc, a treatment for osteoarthritis of the knee, triggering a $20 million milestone payment from marketing partner Ortho Biotech Product LP.
The firms expect to launch Orthovisc in conjunction with the annual meeting of the American Academy of Orthopedic Surgeons in San Francisco held March 10-14, Anika said.
Woburn, Mass.-based Anika's stock (NASDAQ:ANIK) closed Thursday at $10, up 99 cents, or 11 percent.
Orthovisc, a highly purified, high-molecular-weight form of hyaluronic acid, is indicated for treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics, such as acetaminophen. The product has been on the market internationally since 1996 and is sold in Canada and certain European and Middle Eastern countries.
While officials at Anika were not available for comment, Charles Sherwood, the firm's CEO, released a prepared statement saying FDA approval is a major milestone for the company. "Given the strength of our safety and efficacy data from the Orthovisc clinical trials, we believe there is a significant opportunity to penetrate the U.S. market for viscosupplementation therapy for the treatment of pain from osteoarthritis of the knee," he said.
Sherwood estimated the annual U.S. market at about $350 million.
Anika and Ortho Biotech, a subsidiary of Johnson & Johnson, of New Brunswick, N.J., in late December entered an exclusive multiyear licensing and supply agreement for Orthovisc. The deal included a $2 million up-front fee for Anika, plus the $20 million milestone on FDA approval.
A company official with Ortho Biotech, located in Bridgewater, N.J., declined to discuss further financial arrangements related to Orthovisc. However, a prepared statement from the company said the agreement also calls for potential additional payments contingent on achieving performance and sales threshold milestones, in addition to royalty and transfer fees.
FDA approval of Orthovisc is based on two randomized, controlled, double-blind, multicenter Phase III U.S. trials of 458 patients with osteoarthritis of the knee. Safety data from a third U.S. trial also were included in the application.
Orthovisc is introduced into the knee joint in a series of intra-articular injections one week apart. The drug is designed to coat, lubricate and protect joint tissues, providing the viscoelastic and cushioning properties of natural hyaluronic acid found in the synovial fluid of healthy joints.
Anika has not had an easy time getting Orthovisc to market in the U.S.
In June 2000, the company's value dropped 65 percent, or $4.75, to close at $2.50 when a Phase III study for the candidate failed. In late 1998, the FDA had said clinical data possessed by the company at that time were not sufficient for approval. As a result, the firm had to initiate another trial. (See BioWorld Today, Jan. 6, 1998; March 30, 1999; and June 1, 2000.)
At one time, the product was partnered with Zimmer Inc., a subsidiary of New York-based Bristol-Myers Squibb Co. An Anika official told BioWorld Today the Zimmer deal, once valued at $23 million, fell through after Orthovisc failed to make it to market in 2000.